Serp-1 for the Treatment of Acute Coronary Syndrome

Phase 2

Terminated

• Conditions: Unstable Angina; Coronary Atherosclerosis; Coronary Restenosis

• Registration Number: NCT00243308
• Lead Sponsor: Viron Therapeutics Inc

Brief Summary

Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.

Detailed Description

A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-21
• Primary Completion: 2008-07
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
• Scheduled for PCI

Exclusion Criteria

• CABG within 6 months
• Acute ST elevation, eligible for thrombolysis on initial examination
• Coronary lesions with total thrombotic occlusions
• Current immunosuppressant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety (Adverse events collected until 6 months post-dose)

Secondary Outcome Measures

Name	Time	Method
Inflammatory marker analysis
MACE
Restenosis at 6 months

Trial Locations

Locations (8)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

University of Florida; 🇺🇸 Gainesville, Florida, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Victoria Heart Institute; 🇨🇦 Vicotria, British Columbia, Canada

Foothills Medical Center; 🇨🇦 Calgary, Ontario, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada